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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00468156 |
The main aim of this study is to determine if persons can increase fruit and vegetable intakes if they make a specific plan to do so.
Condition | Intervention |
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Cancer |
Behavioral: written materials only Behavioral: written materials Behavioral: telephone support |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Implementation Intentions for Improving Fruit and Vegetable Intakes |
Enrollment: | 97 |
Study Start Date: | September 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
written materials only
|
Behavioral: written materials only
related to fruit/vegetable servings/day
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2: Experimental
written materials plus asked to form implementation intentions
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Behavioral: written materials
related to fruit/vegetable servings/day
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3: Experimental
same as arm 2 plus telephone support
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Behavioral: telephone support
related to fruit/vegetable servings/day
|
The conduct of cancer prevention trials through community settings and/or national networks of clinical sites requires the development of appropriate interventions. One promising behavioral strategy that is very simple to administer is that of the formulation of implementation intentions. The premise of this intervention is that once persons formulate a plan of action, automatic behavior follows. Use of this intervention in primary care is an innovative approach to eliciting preventive behaviors with minimal staff time. The goal in this study will be to increase fruit and vegetable consumption by 2 servings/day without a change in overall energy intakes by decreasing consumption of a less nutritious food. Substitution of foods is critical for prevention of weight gain. This feasibility study aims conduct a randomized, controlled clinical trial to test whether formulation of implementation intentions, either alone or with telephone support, can increase fruit and vegetable consumption without an increase in overall energy intakes. Recruitment success in a family medicine clinic in Ypsilanti Michigan will be documented with emphasis on the extent of minority participation. Dietary assessment will be the main outcome variable. Other assessments will include demographics, self-assessment of behaviors targeted by the intervention and levels of carotenoids in plasma. We will enroll 105 subjects to retain 28/arm, and power is good to detect small differences in fruit and vegetable intakes among the three study arms. This will generate useful data for the design of larger dietary intervention trials that are cost-effective and which will utilize multiple clinical sites to optimize enrollment.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Ypsilanti Family Health Center | |
Ypsilanti, Michigan, United States, 48197 |
Principal Investigator: | Zora Djuric, PhD | University of Michigan |
Responsible Party: | University of Michigan |
Study ID Numbers: | HUM00004225 |
Study First Received: | April 30, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00468156 History of Changes |
Health Authority: | United States: Institutional Review Board |
fruit vegetables prevention |
cancer counseling cancer risk |